<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20200217046527N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-03-19</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>"The effect of Acceptance and Commitment Therapy (ACT) protocol on women with infertility"</public_title>
      <acronym></acronym>
      <scientific_title>Revising of Acceptance and Commitment Therapy (ACT) protocol based on psychological problems in women with infertility and (its) effectiveness on their health- related quality of life and sexual satisfaction in women with infertility.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46024</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Education/Guidance, Randomization description: Since the study groups have equal sample size, we use simple random allocation law which is one of the limited randomization methods and we divide people into two groups of intervention and control. Keep notes of patients on 40 separate sheets and place the sheets inside the draw container and then we randomly record the 20 sheets out of the container into the intervention group and place the remaining 20 sheets in the control group. If there is a loss in treatment sessions, the sample size will be randomly eliminated in order to equalize the sample size and eventually the number of subjects in both groups should be the same. The experimental group (n=20) will have 8 sessions of 120-minute Acceptance and Commitment therapy and the control group will receive no intervention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>women with infertility.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Acceptance and Commitment Therapy (ACT) has six central processes that lead to psychological flexibility. These six processes are: "Acceptance, Faulting, self as context, present-day communication, recognizing values ​​and committed action Intervention group". In fact the purpose of Acceptance and Commitment therapy, is not to make a direct change in the client. Rather, its purpose is to help clientele communicate their experiences in different ways and be able to engage completely with meaningful, value-based life. The proposed protocol is based on the Acceptance and Commitment Book by Hayes, Straussell and Wilson. In the intervention group: Twenty patients have prostate cancer before the protocol is implemented In the pre-test, they completed the Short Form of sexual satisfaction and Health-Related Quality of Life (SF-36) with full specifications. In the intervention group, the Acceptance and Commitment Therapy protocol (ACT) will be conducted in eight consecutive 90-minute sessions in 4 consecutive weeks. Intervention 2: Control group: Twenty patients with prostate cancer who complete the pre-test questionnaire of sexual satisfaction and health-related quality of life (SF-36) with complete the specification. The group will receive routine care during this 4-week period and will not perform any additional work. After 4 weeks post-test this group will also complete the questionnaires.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is Upon completion of the dissertation the expected outcome will be decided upon.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shiva Koohikamali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 23, Alley 9, Kasra st.</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3144968547</zip>
        <telephone>026344828418</telephone>
        <email>shivakoohi@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>دکتر حمید پورشریفی</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>kodakyar Ave., daneshjo Blvd.,Evin</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۹۸۵۷۱۳۸۳۴</zip>
        <telephone>+98 21 2218 0045</telephone>
        <email>ha.poursharifi@uswr.ac.ir</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>En Willingness to participate in the research project
Age 20-40 years
Having a diploma degree
At least one year under treatment (with expert approval)
No addiction to any drug
Completion of consent to participate in the research
Low Quality of Life Quality of Life and Sexual Satisfaction Questionnaires</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Use of psychoactive drugs</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Acceptance and Commitment Therapy (ACT) has six central processes that lead to psychological flexibility. These six processes are: "Acceptance, Faulting, self as context, present-day communication, recognizing values ​​and committed action Intervention group". In fact the purpose of Acceptance and Commitment therapy, is not to make a direct change in the client. Rather, its purpose is to help clientele communicate their experiences in different ways and be able to engage completely with meaningful, value-based life. The proposed protocol is based on the Acceptance and Commitment Book by Hayes, Straussell and Wilson. In the intervention group: Twenty patients have prostate cancer before the protocol is implemented In the pre-test, they completed the Short Form of sexual satisfaction and Health-Related Quality of Life (SF-36) with full specifications. In the intervention group, the Acceptance and Commitment Therapy protocol (ACT) will be conducted in eight consecutive 90-minute sessions in 4 consecutive weeks.</i_keyword>
      <i_keyword>Control group: Twenty patients with prostate cancer who complete the pre-test questionnaire of sexual satisfaction and health-related quality of life (SF-36) with complete the specification. The group will receive routine care during this 4-week period and will not perform any additional work. After 4 weeks post-test this group will also complete the questionnaires.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Scale on sexual satisfaction ; Physical and Mental Health Score in Health Related Quality of Life Questionnaire (SF 36). Timepoint: At the beginning of the study (before the intervention) and after 8 sessions of acceptance and commitment group therapy. Method of measurement: Health Related Quality of Life Questionnaire (SF 36); sexual satisfaction.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Health-related quality of life score and Scale on sexual satisfaction. Timepoint: Health-related Quality of Life Questionnaires (SF 36) and Scale on sexual satisfaction at baseline (before intervention) and after treatment protocol. Method of measurement: The sexual satisfaction Questionnaire (DASS 21) Health-related quality of life (SF 36).</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-12-07</approval_date>
        <contact_name>Ethics committee of Hormozgan University of Medical Sciences</contact_name>
        <contact_address>Shahid Chamran Blvd., Hormozgan University of Medical Sciences Bandar Abbas Hormozgan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
